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FDA 510(k)

SIME POWDERFREE PLUS

K-Number: K954051 · 1995-11-15

ApplicantSime Health, Ltd.
Decision Date1995-11-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIME POWDERFREE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sime Health, Ltd.. It received FDA 510(k) clearance on 1995-11-15 under 510(k) number K954051. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIME POWDERFREE PLUS?

SIME POWDERFREE PLUS is a medical device that received FDA 510(k) clearance on 1995-11-15. The listed applicant is Sime Health, Ltd.. The 510(k) number is K954051.

When did SIME POWDERFREE PLUS receive FDA 510(k) clearance?

SIME POWDERFREE PLUS received FDA 510(k) clearance on 1995-11-15, under 510(k) number K954051.

Who is the listed applicant for SIME POWDERFREE PLUS?

The FDA 510(k) record lists Sime Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIME POWDERFREE PLUS?

The FDA product code for SIME POWDERFREE PLUS is LYY.

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Other records listing Sime Health, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954025SIME SURGICAL POWDERFREEK932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFIK932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFIK932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K940797SIME SURGICAL LATEX GLOVE

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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